Alexandre Michalis
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Alexandre Michalis Email & Phone Number

Medtech R&D passionate | Build the teams that shape the Neurotech's future | Looking to reimagine healthcare at Neurosoft Bioelectronics
Location: Le Grand-Saconnex, Geneva, Switzerland 12 work roles 4 schools
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Role
Medtech R&D passionate | Build the teams that shape the Neurotech's future | Looking to reimagine healthcare
Location
Le Grand-Saconnex, Geneva, Switzerland
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Alexandre Michalis is listed as Medtech R&D passionate | Build the teams that shape the Neurotech's future | Looking to reimagine healthcare at Neurosoft Bioelectronics, a company with 22 employees, based in Le Grand-Saconnex, Geneva, Switzerland. AeroLeads shows a matched LinkedIn profile for Alexandre Michalis.

Alexandre Michalis previously worked as Head of Product Development at Neurosoft Bioelectronics and Chief Technology Officer at Aleva Neurotherapeutics Sa. Alexandre Michalis holds Ingénieur, Micro & Nano-Systèmes from Epfl.

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Neurosoft Bioelectronics

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About Alexandre Michalis

Over 14 years of experience in Research and Development, Verification & Validation and Manufacturing of Class III Active Implantable Medical Devices. Since 5 years living the experience of a Program Manager involved in bringing the medical device on the market, training users, participating in surgeries and patient programming sessions.Expertise:- FDA pre-sub and IDE process experience until IDE approval- MDR 2017/745 (EU) and ISO 13485:2016 knowledge- Customer support for patients and clinicians in the EU- In-vivo long-term study leading with different external labs- FELASA category C accredited Education- Optical and Electrical Incoming control on more than 1000 devices- Expertise in SEM/FIB advanced imaging systems for nanostructure analysis- Cleanroom process control of Class III medical devices- ISO-10993 Biocompatibility testing- Risk Management per 14155

Listed skills include R&D, Medical Devices, Iso 13485, Nanotechnologie, and 18 others.

Current workplace

Alexandre Michalis's current company

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Neurosoft Bioelectronics
Neurosoft Bioelectronics
Medtech R&D passionate | Build the teams that shape the Neurotech's future | Looking to reimagine healthcare
Grand-Saconnex, GE, CH
Employees
22
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12 roles · 21 years

Alexandre Michalis work experience

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Head Of Product Development

Current

Geneva, CH

My role as Head of Product Development is to lead and support all design and development activitiesfor the company's medical devices. This role is crucial in ensuring the successful delivery of innovative and high-quality products that meet both market needs and regulatory requirements.My duties are:° Oversee and coordinate the entire product development.

Aug 2024 - Present

Chief Technology Officer

Lausanne, VD, CH

° Responsible for Developing and implementing the company's technology roadmap° Define company strategy and objectives with Board of Directors and C-Level° Overseeing the development of new products and services° Building and leading the technology teamIn summary, as the CTO, my mission is to foster a culture of trust, open-mindedness, and creativity.

Mar 2023 - Jul 2024

Director Of Product Development & Product Manager

Lausanne, VD, CH

° Setting-up the strategy, roadmap, and vision for the directSTIM product line° Secured CE-mark for Class III AIMD as a result of extraordinary teamwork of highly skilled, passionate and healthy team members° Involved with submission of Design Dossier to notified body for CE-approval° Passionate Leader of skilled cross-functional engineering, marketing.

Mar 2017 - Mar 2023

Project Manager

Lausanne, VD, CH

° Responsible for Design and Development of a MDD class III Intra-Surgical Multiple Electrode Lead for Deep Brain Stimulation (DBS) surgeries in Movement Disorders.° Construction of a clinical Dossier and interaction with ethics committee and Swiss agency for authorization and market supervision of all therapeutic and medical products.° Project Manager of.

Feb 2015 - Feb 2017

Sr. Development & Verification Engineer

Lausanne, VD, CH

° Device Validation Testing (DVT) and preliminary design/concept studies° In-vivo long-term studies and in-vitro long-term testing° Responsible for animal stereotactic surgeries and follow-up° Writing and reviewing of verification protocols and plans° European FELASA cat. C certificate

Feb 2014 - Jan 2015

R&D Engineer

Lausanne, VD, CH

Involved in:° Quality Management System implementation° Clinical affairs and product verification & validation° Writing of protocols and reports° Conducting preliminary and approved tests° Developing custom tools for specific tests.

Dec 2010 - Jan 2014

Ingénieur Biomédical En Chirurgie Cardio-Vasculaire

Lausanne, CH

Development of external BiVADs (Bi Ventricular Assists Devices) based on artificial muscles. Physiologic muscle movement is reproduced using SMAs (Shape Memory Alloys)

Oct 2009 - Sep 2011

Ingénieur

Lausanne, Vaud, CH

Micro and Nano-systems engineer, Master degree achieved with the help of Prof. Renaud and his lab LMIS4.

2009 - 2010 ~1 yr

Consultant

Nanopowers Sa

Our first aim was to create an interface where the consumption of a given actuatorcould be calculated as a function of the muscle wire length and the input power necessary tooperate any medical implantable system using SMAs. In addition we also integrated theevaluation of the operative duration of two different commercially available implantablebatteries.

Feb 2009 - Jun 2009

Etudiant

Neuchâtel, CH

Clean room experience. Fabrication of solar cells.

2005 - 2008 ~3 yrs
Team & coworkers

Colleagues at Neurosoft Bioelectronics

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4 education records

Alexandre Michalis education

Ingénieur, Micro & Nano-Systèmes

Epfl

Bachelor, Micro-& Nanosciences

Université De Neuchâtel

Building Game-Changing Organizations: Aligning Purpose, Performance, And People, Strategy And Innovation

Massachusetts Institute Of Technology

Building, Leading, And Sustaining The Innovative Organization, Leadership Éducatif Et Administration, Général

Massachusetts Institute Of Technology
FAQ

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What company does Alexandre Michalis work for?

Alexandre Michalis works for Neurosoft Bioelectronics.

What is Alexandre Michalis's role at Neurosoft Bioelectronics?

Alexandre Michalis is listed as Medtech R&D passionate | Build the teams that shape the Neurotech's future | Looking to reimagine healthcare at Neurosoft Bioelectronics.

Where is Alexandre Michalis based?

Alexandre Michalis is based in Le Grand-Saconnex, Geneva, Switzerland while working with Neurosoft Bioelectronics.

What companies has Alexandre Michalis worked for?

Alexandre Michalis has worked for Neurosoft Bioelectronics, Aleva Neurotherapeutics Sa, Chuv, Myopowers Medical Technologies Sa, and Epfl.

Who are Alexandre Michalis's colleagues at Neurosoft Bioelectronics?

Alexandre Michalis's colleagues at Neurosoft Bioelectronics include David Dianor, Maxim Gorbunov, Chloé Fattebert, Ludovic Serex, and Nathanaëlle Weber.

How can I contact Alexandre Michalis?

You can use AeroLeads to view verified contact signals for Alexandre Michalis at Neurosoft Bioelectronics, including work email, phone, and LinkedIn data when available.

What schools did Alexandre Michalis attend?

Alexandre Michalis holds Ingénieur, Micro & Nano-Systèmes from Epfl.

What skills is Alexandre Michalis known for?

Alexandre Michalis is listed with skills including R&D, Medical Devices, Iso 13485, Nanotechnologie, Mems, V&V, Pre Clinical Studies, and Sensors.

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